CBER's Office of Compliance and Biologics Quality (OCBQ) directs the CBER-regulated product shortage program, which includes product discontinuations.
The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) made substantial changes to section 506C of the FD&C Act related to reporting and addressing interruptions in manufacturing or permanent discontinuances of certain drug products. For example, FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products. More information on FDASIA is provided on FDA’s FDASIA Fact Sheet Page.
Shortages of drugs and biologics pose a significant public health threat, delaying, and in some cases even denying, critically needed care for patients. Preventing shortages remains a top priority for FDA. For more information please see FDA Facts: Drug Shortages in the United States.
Additional information regarding possible causes of CBER-regulated product shortages is provided on the CBER-Regulated Products: Possible Causes of Shortages Page.